Study on How an Edible Film Affects Saliva Production in Healthy Older Adults

Evaluation of the Safety and Usefulness of a Newly Developed Flavored Edible Film for Healthy Older Adults, and Validation of Its Assessment Methods - Evaluation of the Safety, Usefulness, and Assessment Methods of an Edible Film in Healthy Older Adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059923

Enrollment

Registered

2026-01-01

Start date

2026-01-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy older adults (no specific disease)

Interventions

Edible film: Participants ingest one sheet orally, followed by measurements of salivary volume, taste stimulation response, EEG activity, and facial expression changes. A total of four edible films w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals aged 65 years or older. 2. Individuals who correctly answered both items on the olfactory nerve test. 3. Individuals without any restriction of mouth opening. 4. Individuals with no olfactory dysfunction.

Exclusion criteria

Exclusion criteria: 1. Individuals with restricted mouth opening. 2. Older adults with structural abnormalities of the oral cavity or upper gastrointestinal tract that make swallowing saliva difficult. 3. Individuals who have symptoms of a cold on the day of the experiment.

Design outcomes

Primary

Measure	Time frame
No significant increase in salivary volume 10 seconds after ingesting the edible film	—

Secondary

Measure	Time frame
Ingestion of the edible film results in the observation of the emotional states Expectant and Impressed in EEG measurements. Ingestion of the edible film results in the observation of the facial expressions Joy and Surprise in facial expression analysis.	—

Countries

Japan

Contacts

Public ContactKiyoshi HOTTA

College of Life and Health Sciences, Chubu University Department of Nursing

k_hotta@fsc.chubu.ac.jp09051022349

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026